FDA Device recall Z-1409-2021
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex
- FDA Device
- Class III
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class III recall of Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex by Origen Biomedical, citing it was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1409-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-01-28 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Origen Biomedical |
| Distribution | CA, CT, FL, IA, IL, KS, LA, MA, MD, NC, NJ, NY, OH, OR, PA, PR, RI, TN, TX |
Product
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps
Reason
It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1409-2021%22
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